FDA: Eczema Products Must Warn About Increased Cancer Risks
On January 19, 2006 the FDA announced that two eczema products, Elidel and Protopic, must have a "black-box" warning placed on their package insert, or label, warning that these skin medications have a potential increased cancer risk and that their long-term safety has not been established.
Eczema, or atopic dermatitis, is a chronic condition that causes dry, scaly patches on the skin that itch and can bleed. According to the FDA, eczema affects 10% to 15% of the child-age population, making it one of the most common skin disorders seen in infants and children.
Elidel and Protopic are prescription medications, or ointments, that are applied to the skin areas with symptoms of eczema. According to the FDA, essentially Elidel and Protopic treat eczema by suppressing the body's immune system. Some animal studies have suggested that this immunosuppression which results from dermal exposure to Elidel and Protopic causes an increased risk of cancer.
An article published by Reuters on January 19, 2006 reported about why the FDA finally (see below) decided to order the black-box warning for Elidel and Protopic:
"Food and Drug Administration officials said while a clear link between the drugs and cancer risk had not been found, there have been enough cancer reports to warrant the change. A total of 78 cases were reported for both products as of October 2005, they said.
" 'The concern that is being highlighted today is that the long-term safety of these products has not been established,' Dr. Julie Beitz, an acting office director within the FDA's office of drug evaluation, said."
Remarkably, this FDA action comes almost a full year after an FDA advisory panel, in February 2005, recommended to the agency that Elidel and Protopic have a black-box warning added to their respective labels. In March 2005 the FDA issued a statement to the effect that it agreed with the advisory panel's recommendation, and that it would require these prescription skin ointments to carry a black-box warning.
However, in the ten months leading up to the January 2006 FDA announcement, Novartis AG, the maker of Elidel, and Astellas Pharma Inc., the maker of Protopic, were successful in delaying the placement of any black-box warning on their skin cream medications.
This situation was characterized by a January 20, 2006 article in The Wall Street Journal in this manner: "Since [March 2005], the companies and the FDA have been haggling over the final wording."
No wonder there is widespread doubt about who is in control of drug safety in the U.S. -- the FDA, or Big Pharma.
(Posted by: Tom Lamb)